Download Dextrose Injection, USP

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Document No.: 07-19-50-507
Change No.: CP0137276
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07-19-50-507
Dextrose Injection, USP
in AVIVA Plastic Container
Description
Indications and Usage
Dextrose Injection, USP is a sterile, nonpyrogenic solution for
fluid replenishment and caloric supply in single dose containers for
intravenous administration. It contains no antimicrobial agents.
Composition, osmolarity, pH, and caloric content are shown in Table 1.
Dextrose Injection, USP is indicated as a source of water and calories.
Table 1
Date
* Dextrose
Hydrous,
Size
(mL)
USP (g/L)
Osmolarity
(mOsmol/L)
(calc.)
pH
nominal
(range)
Contraindications
Solutions containing dextrose may be contraindicated in patients with
known allergy to corn or corn products.
Caloric
Content
(kcal/L)
5% Dextrose
Injection, USP
250
500
1000
50
252
4.5
(3.2 to 6.5)
170
10% Dextrose
Injection, USP
250
500
1000
100
505
4.5
(3.2 to 6.5)
340
*
Warnings
Dextrose Injection, USP should not be administered simultaneously with
blood through the same administration set because of the possibility of
pseudoagglutination or hemolysis.
The intravenous administration of these solutions can cause fluid
and/or solute overloading resulting in dilution of serum electrolyte
concentrations, overhydration, congested states, or pulmonary edema.
The risk of dilutive states is inversely proportional to the electrolyte
concentrations of the injections. The risk of solute overload causing
congested states with peripheral and pulmonary edema is directly
proportional to the electrolyte concentrations of the injections.
Excessive administration of dextrose injections may result in significant
hypokalemia.
In very low birth weight infants, excessive or rapid administration of
dextrose injection may result in increased serum osmolality and
possible intracerebral hemorrhage.
Precautions
D-Glucose monohydrate
The flexible container is made with non-latex plastic materials specially
designed for a wide range of parenteral drugs including those requiring
delivery in containers made of polyolefins or polypropylene. For
example, the AVIVA container system is compatible with and
appropriate for use in the admixture and administration of paclitaxel. In
addition, the AVIVA container system is compatible with and appropriate
for use in the admixture and administration of all drugs deemed
compatible with existing polyvinyl chloride container systems. The
solution contact materials do not contain PVC, DEHP, or other
plasticizers.
The suitability of the container materials has been established through
biological evaluations, which have shown the container passes Class VI
U.S. Pharmacopeia (USP) testing for plastic containers. These tests
confirm the biological safety of the container system.
The flexible container is a closed system, and air is prefilled in the
container to facilitate drainage. The container does not require entry of
external air during administration.
The container has two ports: one is the administration outlet port for
attachment of an intravenous administration set and the other port has
a medication site for addition of supplemental medication (See
Directions for Use). The primary function of the overwrap is to protect
the container from the physical environment.
Clinical Pharmacology
Dextrose Injection, USP has value as a source of water and calories.
It is capable of inducing diuresis depending on the clinical condition of
the patient.
General
Do not connect flexible plastic containers of intravenous solutions in
series connections. Such use could result in air embolism due to
residual air being drawn from one container before administration of the
fluid from a secondary container is completed.
Pressurizing intravenous solutions contained in flexible plastic containers
to increase flow rates can result in air embolism if the residual air in the
container is not fully evacuated prior to administration.
Use of a vented intravenous administration set with the vent in the open
position could result in air embolism. Vented intravenous administration
sets with the vent in the open position should not be used with
flexible plastic containers.
Dextrose Injection, USP should be used with caution in patients with
overt subclinical diabetes mellitus.
Laboratory Tests
Clinical evaluation and periodic laboratory determinations are necessary
to monitor changes in fluid balance, electrolyte concentrations, and acid
base balance during prolonged parenteral therapy or whenever the
condition of the patient warrants such evaluation.
Drug Interactions
Studies have not been conducted to evaluate additional drug/drug or
drug/food interactions with Dextrose Injection, USP.
Carcinogenesis, mutagenesis, impairment of fertility
Studies with Dextrose Injection, USP have not been performed to
evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Date
Confidential Property of Baxter Healthcare Corporation and its Affiliates
PROOFREADING INSPECTION / RELEASED ARTWORK
Document No.: 07-19-50-507
Change No.: CP0137276
Page 2 of 2
Proofreading Approval ________________________ ________________________ ________
Print Name
Signature
Date
Proofreading Approval ________________________ ________________________ ________
Print Name
Signature
P1 07/13/2006 CMD
Colors: PMS 287 Blue
Pregnancy: Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been
conducted with Dextrose Injection, USP. It is also not known whether
Dextrose Injection, USP can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Dextrose
Injection, USP should be given to a pregnant woman only if
clearly needed.
Additives may be incompatible. Complete information is not available.
Those additives known to be incompatible should not be used. Consult
with pharmacist, if available. If, in the informed judgment of the
physician, it is deemed advisable to introduce additives, use aseptic
technique. Mix thoroughly when additives have been introduced.
Do not store solutions containing additives.
Labor and Delivery
Studies have not been conducted to evaluate the effects of Dextrose
Injection, USP on labor and delivery. Caution should be exercised when
administering this drug during labor and delivery.
Dextrose Injection, USP in AVIVA plastic container is available
as follows:
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised
when Dextrose Injection, USP is administered to a nursing mother.
6E0062
6E0063
6E0064
6E0162
6E0163
6E0164
Pediatric Use:
Dextrose Injection, USP is safe and effective for the stated indications in
pediatric patients (see Indications and Usage). As reported in the
literature, the dosage selection and constant infusion rate of intravenous
dextrose must be selected with caution in pediatric patients, particularly
neonates and low birth weight infants, because of the increased risk of
hyperglycemia/hypoglycemia. Frequent monitoring of serum glucose
concentrations is required when dextrose is prescribed to pediatric
patients, particularly neonates and low birth weight infants.
Geriatric Use
Clinical studies of Dextrose Injection, USP did not include sufficient
numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical
experience has not identified differences in responses between the
elderly and younger patients. In general, dose selection for an elderly
patient should be cautious, usually starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal, or
cardiac function and of concomitant disease or drug therapy.
This drug is known to be substantially excreted by the kidney, and the
risk of toxic reactions to this drug may be greater in patients with
impaired renal function. Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection,
and it may be useful to monitor renal function.
Adverse Reactions
Reactions which may occur because of the injection or the technique of
administration include febrile response, infection at the site of injection,
venous thrombosis or phlebitis extending from the site of injection,
extravasation and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the
patient, institute appropriate therapeutic countermeasures and save the
remainder of the fluid for examination if deemed necessary.
Dosage and Administration
As directed by a physician. Dosage is dependent upon the age, weight
and clinical condition of the patient as well as laboratory determinations.
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration whenever solution and
container permit.
Do not administer unless solution is clear and seal is intact.
All injections in AVIVA plastic containers are intended for intravenous
administration using sterile equipment.
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
Printed in USA
How Supplied
Code
Size (mL)
250
500
1000
250
500
1000
NDC
Product Name
0338-6346-02
0338-6346-03
0338-6346-04
0338-6347-02
0338-6347-03
0338-6347-04
5% Dextrose Injection, USP
10% Dextrose Injection, USP
Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. It is recommended the product be stored at room
temperature (25°C/77°F); brief exposure up to 40°C/104°F does not
adversely affect the product.
Directions for Use of AVIVA Plastic Container
To Open
Tear overwrap down side at slit and remove solution container.
Moisture and some opacity of the plastic due to moisture absorption
during the sterilization process may be observed. This is normal and
does not affect the solution quality or safety. The opacity will diminish
gradually. Check for minute leaks by squeezing inner bag firmly. If
leaks are found, discard solution as sterility may be impaired. If
supplemental medication is desired, follow “To Add Medication”
directions below.
Preparation for Administration
Caution: Do not use plastic containers in series connections.
Caution: Use only with a non-vented set or a vented set with the vent
closed.
1. Suspend container from eyelet support.
2. Remove protector from outlet port at bottom of container.
3. Attach administration set. Refer to complete directions
accompanying set.
To Add Medication
Additives may be incompatible.
To add medication before solution administration
1. Prepare medication site.
2. Using syringe with 19 to 22 gauge needle, puncture resealable
medication port and inject.
3. Mix solution and medication thoroughly. For high density medication
such as potassium chloride, squeeze ports while ports are upright
and mix thoroughly.
To add medication during solution administration
1. Close clamp on the set.
2. Prepare medication site.
3. Using syringe with 19 to 22 gauge needle, puncture resealable
medication port and inject.
4. Remove container from IV pole and/or turn to an upright position.
5. Evacuate both ports by squeezing them while container is in the
upright position.
6. Mix solution and medication thoroughly.
7. Return container to in-use position and continue administration.
07-19-50-507
Rev. April 2006
Baxter and AVIVA are trademarks of Baxter International Inc.
*BAR CODE POSITION ONLY
071950507
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ON ART AND ON SPEC. DO NOT ALTER HUMAN READABLE INFORMATION ON ART. BAR CODE MUST CONFORM TO ALL APPLICABLE BAXTER SPECS.
Date